On February 21, 2024, Senator Bill Cassidy (R-LA), the Ranking Member of the U.S. Senate Health, Education, Labor, and Pensions (“HELP”) Committee, issued a white paper, “Strengthening Health Data Privacy for Americans: Addressing the Challenges of the Modern Era,” which proposes several updates to the privacy protections for health data. This follows Senator Cassidy’s
Health Care
Virtual and Digital Health Digest, February 2024
This digest covers key virtual and digital health regulatory and public policy developments during January 2024.…
The UK’s pro-innovation approach to AI: What does this mean for life science companies?
A version of this article was first published in Life Sciences IP Review
There is currently no specific legislation in the UK that governs AI, or its use in healthcare. Instead, a number of general-purpose laws apply that have to be adapted to specific AI technologies. As a step towards a more coherent approach, the government…
Monumental Reduction in FCA Damages Based on Excessive Fines Clause
In a recent landmark decision, the United States District Court for the District of Minnesota dramatically reduced the damages and penalties awarded in a major False Claims Act (“FCA”) case. United States of America ex rel. Kipp Fesenmaier v. The Cameron-Ehlen Group, Inc., et al., Case No. 13-cv-3003 (D. Minn., Feb. 8 2024) (Dkt. 1086).…
HHS Addresses the Growing Influence of Artificial Intelligence in Health Care
This post was co-authored by Blair Robinson, a member Robinson+Cole’s Artificial Intelligence Team.
Artificial Intelligence (AI) has emerged as a major player in the realm of health care, promising to completely transform its delivery. With AI’s remarkable ability to analyze data, learn, solve problems, and make decisions, it has the potential to enhance patient…
WHO Publishes Guidance for Ethics and Governance of AI for Healthcare Sector
The World Health Organization (WHO) recently published “Ethics and Governance of Artificial Intelligence for Health: Guidance on large multi-modal models” (LMMs), which is designed to provide “guidance to assist Member States in mapping the benefits and challenges associated with the use of for health and in developing policies and practices for appropriate development,…
Landmark UK High Court decision makes it easier to patent AI-related inventions that utilise ANNs
The end of 2023 featured two significant judgments concerning AI inventions: (i) a highly awaited decision from the Supreme Court in Thaler on the ability of AI systems to be named inventors of patents; and (ii) a decision from the High Court in Emotional Perception considering the application of the computer program exclusion in the…
The First Virtual and Digital Health Digest of 2024
Welcome to the first Virtual and Digital Health Digest of 2024!…
ONC Finalizes Information Sharing and Algorithm Transparency Rule
The Department of Health and Human Services Office of the National Coordinator for Health Information Technology (ONC) has published its first final rule on Health Data, Technology and Interoperability. The rule, known as the HTI-1 rule, takes effect on February 8, and governs updates to the ONC’s Health IT Certification Program, as well as regulations…
AI, Phishing Attacks, Healthcare, and a $480,000 OCR Settlement under HIPAA
Phishing has long been a favorite tactic for threat actors (hackers) to commence a cyberattack. The rapid expansion of more adaptable and available artificial intelligence (AI) technologies, such as natural language processing and large language models, now fuels more ferocious phishing campaigns. The effects are being felt in many industries, perhaps most notably the healthcare…